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<title>IEthics Review Application (Part II)  Summary of Evaluation</title>
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<h1>
<br/>Faculty of Medicine, University of Colombo<br/>
Ethics Review Application (Part II)  Summary of Evaluation<br/></h1>

for official use<br/>


Application No:<input type="text" name="Application No"/><br/>
<br/>
<h3>THIS IS TO BE FILLED BY THE REVIWER<br/><br/><br/></h3>
<form>
Are the investigators qualifications and experience appropriate to conduct the study?  
Yes<input type="radio"name="yn" value="yes"/> 
No<input type="radio"name="yn" value="no"/><br/><br/>

Collaborative partnership<br/>			
* Develop partnerships with researchers, makers of health policies, and the community.<br/>
* Involve partners in sharing responsibilities for determining the importance of health problem, assessing the value of research, planning, conducting, and overseeing research, and integrating research into the health-care system.<br/>
* Respect the communitys values, culture, traditions, and social practices.<br/>
* Develop the capacity for researchers, makers of health policies, and the community to become full and equal partners in the research enterprise.<br/>
* Ensure that recruited participants and communities receive benefits from the conduct and results of research.<br/>
* Share fairly financial and other rewards of the research.<br/>

           
Acceptable<input type="radio"name="ac1" value="acc"/> 
Concerns<input type="radio"name="ac1" value="con"/>(state below)<br/><br/>

Social or scientific Value<br/>
* Specify the beneficiaries of the researchwho.<br/>
* Assess the importance of the health problems being investigated and the prospective value of the research for each of the beneficiarieswhat.<br/>
* Enhance the value of the research for each of the beneficiaries through dissemination of knowledge, product development, long-term research collaboration, and/or health system improvements.<br/>
* Prevent supplanting the extant health system infrastructure and services.<br/>
       
Acceptable<input type="radio"name="ac2" value="acc"/> 
Concerns<input type="radio"name="ac2" value="con"/>(state below)<br/><br/>

Scientific Validity	<br/>		
* Ensure that the scientific design of the research realizes social value for the primary beneficiaries of the research.<br/>
* Ensure that the scientific design realizes the scientific objectives while guaranteeing research participants the health-care interventions to which they are entitled.<br/>
* Ensure that the research study is feasible within the social, political, and cultural context or with sustainable improvements in the local health-care and physical infrastructure.<br/>

Acceptable<input type="radio"name="ac3" value="acc"/> 
Concerns<input type="radio"name="ac3" value="con"/>(state below)<br/><br/>

Fair Subject Selection<br/>
* Select the study population to ensure scientific validity of the research.<br/>
* Select the study population to minimize the risks of the research and enhance other principles, especially collaborative partnership and social value.<br/>
* Identify and protect vulnerable populations.<br/>

Acceptable<input type="radio"name="ac4" value="acc"/> 
Concerns<input type="radio"name="ac4" value="con"/>(state below)<br/><br/>

Favourable Risk benefit ratio<br/>
* Assess the potential risks and benefits of the research to the study population in the context of its health risks.<br/>
* Assess the risk-benefit ratio by comparing the net risks of the research project with the potential benefits derived from collaborative partnership, social value, and respect for study populations.<br/>

Acceptable<input type="radio"name="ac5" value="acc"/> 
Concerns<input type="radio"name="ac5" value="con"/>(state below)<br/><br/>


Independent Review<br/>
* Ensure public accountability through reviews mandated by laws and regulations.<br/>
* Ensure public accountability through transparency and reviews by other international and nongovernmental bodies, as appropriate.<br/>
* Ensure independence and competence of the reviews.<br/>

Appropriate<input type="radio"name="ac6" value="acc"/> 
Concerns<input type="radio"name="ac6" value="con"/>(state below)<br/><br/>

Informed Consent<br/>
* Involve the community in establishing recruitment procedures and incentives.<br/>
* Disclose information in culturally and linguistically appropriate formats.<br/>
* Implement supplementary community and familial consent procedures where culturally appropriate.<br/>
* Obtain consent in culturally and linguistically appropriate formats.<br/>
* Ensure the freedom to refuse or withdraw.<br/>

Appropriate<input type="radio"name="ac7" value="acc"/> 
Concerns<input type="radio"name="ac7" value="con"/>(state below)<br/><br/>

Respect for potential or enrolled subjects<br/>
* Develop and implement procedures to protect the confidentiality of recruited and enrolled participants.<br/>
* Ensure that participants know they can withdraw without penalty.<br/>
* Provide enrolled participants with information that arises in the course of the research study.<br/>
* Monitor and develop interventions for medical conditions, including research-related injuries,<br/>
* for enrolled participants at least as good as existing local norms.<br/>
* Inform participants and the study community of the results of the research.<br/>

Appropriate<input type="radio"name="ac8" value="acc"/> 
Concerns<input type="radio"name="ac8" value="con"/>(state below)<br/><br/>

Information sheet and consent form<br/>

Appropriate<input type="radio"name="ac9" value="acc"/> 
Concerns<input type="radio"name="ac9" value="con"/>(state below)<br/><br/>

Concerns (use next page if required):<br/>

<input type="text" name="Concerns"/><br/> 
<input type="text" name="Concerns"/><br/>
<input type="text" name="Concerns"/><br/> 
<input type="text" name="Concerns"/><br/>
<input type="text" name="Concerns"/><br/>
"
Recommendation:    
Approve <input type="radio"name="ac10" value="app"/> 
Reject<input type="radio"name="ac10" value="reg"/>
Conditional Approval <input type="radio"name="ac10" value="capp"/>(please state the conditions<br/><br/>

Reviewer:<input type="text" name="reviwer"/>  Signature:<input type="text" name="signature"/> Date:<input type="text" name="date"/><br/></form>


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